European Commission
EC approves Roche’s Evrysdi for babies under two months with SMA
August 30, 2023Research and Development European Commission, Evrysdi, Musculo-skeletal disorder, Roche, spinal muscular atrophy
Roche has announced that the European Commission (EC) has approved the extension of Evrysdi’s marketing authorisation in the EU to …
EC approves Kaftrio as combination treatment for cystic fibrosis
April 29, 2021EU, European Commission, cystic fibrosis
Vertex Pharmaceuticals has been granted European Commission approval for the label extension of Kaftrio (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with …
European Commission sues AstraZeneca over COVID-19 jab supplies
April 27, 2021Manufacturing and Production AstraZeneca, AstraZeneca vaccine, COVID-19, EU, European Commission, covid 19 news, covid-19 news, european union, pharma, pharma news
The European Commission (EC) announced yesterday that it was suing AstraZeneca for failing to respect its contract to supply COVID-19 …
Sanofi multiple myeloma drug approved for second indication by EC
April 19, 2021Sales and Marketing European Commission, Sanofi, Sarclisa, pharma, pharma news
The European Commission (EC) has approved a second indication of Sanofi’s Sarclisa drug for the treatment of adult patients with …
Novartis MS therapy gains MHRA and EC approval
April 8, 2021European Commission, MHRA, Novartis, pharma, pharma news
The MHRA and European Commission have both granted marketing authorisation to Novartis for its Kesimpta therapy, for the treatment of …
Roche’s SMA treatment Evrysdi approved by European Commission
March 30, 2021Manufacturing and Production EMA, European Commission, PTC Therapeutics, Roche, sma, spinal muscular atrophy
The European Commission has granted marketing authorisation to Roche and PTC Therapeutics’ Evrysdi, for the treatment of patients aged 2 …
European Commission approves EU’s first peanut allergy treatment
December 21, 2020Sales and Marketing Aimmune, European Commission, allergy
Aimmune Therapeutics today announced that the European Commission (EC) has approved PALFORZIA as the EU’s first-ever treatment of peanut allergy. …
Venclyxto combo scores European approval for previously untreated chronic lymphocytic leukaemia
March 13, 2020Medical Communications, Sales and Marketing AbbVie, European Commission, Roche, Venclyxto, pharma
The European Commission has moved to authorise AbbVie and Roche’s B-cell lymphoma-2 (BCL-2) inhibitor Venclyxto (venetoclax) when used in combination …
Top Ten most popular articles on Pharmafile.com this week
January 17, 2020Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Big Pharma, European Commission, FDA, Pakistan, Sanofi, Teva
Pakistan is cracking down on corruption and has registered cases against 200 pharmaceutical companies, while in the US the FDA …
NICE rules against the use of Akcea’s Waylivra in the NHS
January 3, 2020Medical Communications Akcea, European Commission, FCS, NHS, NICE
NICE has not recommended Akcea’s drug Waylivra (volanesorsen) to be used for the treatment of Familial Chylomicronaemia Syndrome (FCS) in …
Roche’s Tecentriq combo scoops up European approval in first-line metastatic lung cancer
March 8, 2019Medical Communications, Sales and Marketing Cancer, Europe, European Commission, NSCLC, Roche, lung cancer, pharma
Roche has announced the approval of the European Commission for its PD-L1 inhibitor Tecentriq (atezolizumab) when used in combination with …
Amgen’s Blincyto secures expanded indication in Europe for acute lymphoblastic leukaemia
January 23, 2019Research and Development, Sales and Marketing Ammgen, Cancer, Europe, European Commission, blincyto, leukaemia, pharma
The European Commission has chosen to expand the authorised indication for Amgen’s Blincyto (blinatumomab) in the region, it has emerged, …
European Commission greenlights Gilead’s Biktarvy for HIV-1
June 25, 2018Sales and Marketing Biktarvy, EU, Europe, European Commission, HIV, HIV-1, pharma
Good news for Gilead and HIV patients across the European Union today as the prominent pharma firm announced that its …
EMA review confirms risks of Abbvie and Biogen’s Zinbryta outweigh benefits
May 21, 2018Research and Development, Sales and Marketing EMA, Europe, European Commission, PRAC, multiple sclerosis, pharma, zinbryta
The EMA has judged that the benefits offered by Zinbryta (daclizumab), Abbvie and Biogen’s humanised IgG1 monoclonal antibody for the …
Takeda and TiGenix’s Alofisel becomes first donor-derived stem cell therapy approved in Europe
March 26, 2018Sales and Marketing Crohn’s disease, EU, Europe, European Commission, Takeda, TiGenix, crohn's disease, pharma
The European Commission has awarded approval to Takeda and TiGenix’s allogeneic expanded adipose-derived stem cell (eASC) therapy Alofisel (darvadstrocel) for …
